Alnylam decision has been seized by opponents of Medicare price negotiation as evidence the nascent program will undermine innovation, particularly for small molecule drugs.
Rare disease treatment developer Alnylam Pharmaceuticals Inc. has scrapped plans to begin a Phase III study on use of its second-generation RNAi product Amvuttra (vutrisiran) in a second orphan drug indication because having more than one orphan indication could make the drug subject to Medicare price negotiation under the Inflation Reduction Act.
The study would have investigated use of vutrisiran in Stargardt disease, a rare genetic eye disorder that can cause vision...
CMS Administrator Mehmet Oz said PBMs may deserve "one last chance" to fix the rebate system before federal regulations and legislation are enacted.
Expanded confidential pricing for pharmaceuticals is intended to help manage medicines expenditure, according to Amgros, the procurement agency that will negotiate the prices.
The list of essential prescription drugs and related products will shape Canada’s first national formulary for the country’s universal pharmacare program.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.
Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
